Peripheral Arterial Disease Clinical Trial
— VASCULAIDRETROOfficial title:
Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression
NCT number | NCT06206369 |
Other study ID # | 2011279 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 31, 2023 |
Est. completion date | May 1, 2029 |
The VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). The study plans to gather and analyze data from at least 5000 AAA and 6000 PAD patients, combining existing cohorts and retrospectively collected data. During this project, AI tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. AI prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).
Status | Recruiting |
Enrollment | 11000 |
Est. completion date | May 1, 2029 |
Est. primary completion date | May 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - Males and females, 40-90 years old, with an AAA >3cm. This includes patients with infrarenal, juxtarenal, suprarenal, iliac (defined as 1.5x its normal diameter) aneurysms, as well as mycotic aneurysms. Patients that have had interventions or ruptures will also be included - Males and females, 40-90 years old, all PAD patients (Fontaine stages 1,2,3, and 4). Exclusion Criteria: - Patients with an ascending, thoracic, thoracoabdominal (type 1-3) aneurysm. |
Country | Name | City | State |
---|---|---|---|
Finland | Hospital District of Helsinki and Uusimaa (HUS) | Helsinki | |
Germany | Asklepios kliniken hamburg | Hamburg | |
Netherlands | Amsterdam UMC | Amsterdam | |
Portugal | University Hospital Center of São João | Porto | |
Serbia | University Clinical Centre of Serbia | Belgrade | |
United Kingdom | Oxford University Hospitals | Oxford |
Lead Sponsor | Collaborator |
---|---|
Amsterdam UMC, location VUmc | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Asklepios Kliniken Hamburg GmbH, Brightfish Be, Centre Hospitalier Universitaire de Nice, Faculty of Medicine, University of Belgrade, Hospital District of Helsinki and Uusimaa, Stichting Allai, Technical University of Twente, Universidade do Porto, University of Bergen, University of Oxford, VINCA INSTITUTE OF NUCLEAR SCIENCES Belgrado |
Finland, Germany, Netherlands, Portugal, Serbia, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of disease progression prediction algorithms | The primary goal of this retrospective study is to develop and train algorithms to predict disease progression and risk of cardiovascular events in AAA and PAD patients by leveraging multi-parametric data from 5000 AAA (>1000 in AUMC) and 6000 PAD (>1000 in AUMC) patients from existing cohorts and biobanks. | 3 years | |
Secondary | Internal validation of disease progression prediction algorithms | The secondary objective will be the internal validation of the developed algorithms using data from retrospective cohorts. | 3 years |
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